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Tolterodine fumarate oral solid preparation and preparation method thereof

A solid preparation, fumaric acid technology, applied in pharmaceutical formulations, urinary system diseases, drug combinations, etc., to achieve the effect of solving the content uniformity of preparations

Active Publication Date: 2011-03-30
SICHUAN KELUN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

And taking tolterodine fumarate as the oral solid preparation of raw material drug has no report so far, each tablet of tolterodine fumarate only contains tolterodine fumarate 0.93mg or 1.86mg, must add appropriate amount of filling Tolterodine fumarate content uniformity and formulation stability

Method used

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  • Tolterodine fumarate oral solid preparation and preparation method thereof
  • Tolterodine fumarate oral solid preparation and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0022] Embodiment 1: the preparation of tablet

[0023] Take by weighing 0.93g of tolterodine fumarate and 25g of microcrystalline cellulose and grind together through a 100-mesh sieve, mix 50g of starch with the remaining 25g of microcrystalline cellulose and 15g of calcium hydrogen phosphate, and pass through a 100-mesh sieve , the co-researched product and the mixture are mixed in equal amounts and passed through an 80-mesh sieve, stirred evenly, and 5% povidone K is added 30 Ethanol liquid, made into soft material, granulated with a 20-mesh sieve, dried in an oven at 60°C for 2 hours, then granulated with a 20-mesh sieve, plus 0.14g of magnesium stearate as an auxiliary material, mixed to obtain granules, and pressed into tablets , that is.

Embodiment 2

[0024] Embodiment 2: the preparation of capsule

[0025] Take by weighing 1.86g of tolterodine fumarate and 60g of microcrystalline cellulose and grind together through a 100-mesh sieve, mix 30g of starch with the remaining 30g of microcrystalline cellulose and 40g of calcium hydrogen phosphate, and pass through an 80-mesh sieve , the co-research product and the mixture are mixed in equal amounts and passed through a 60-mesh sieve, stirred evenly, and 1% hydroxyethyl methylcellulose ethanol solution is added to make a soft material, granulated with a 12-mesh sieve, and dried in an oven at 80°C After 1 hour, granulate with a 12-mesh sieve, add 0.07 g of talcum powder as an auxiliary material, mix well to obtain granules, put them into empty capsule shells, and obtain.

Embodiment 3

[0026] Embodiment 3: the preparation of tablet

[0027] The tolterodine fumarate 0.93g and 60g microcrystalline cellulose that take by weighing recipe quantity grind together 60 mesh sieves, starch 5g and remaining 120g microcrystalline cellulose, calcium phosphate 10g are mixed, cross 100 mesh sieves, The co-researched product and the mixture were mixed in equal amounts through a 100-mesh sieve, stirred evenly, added 8% methylcellulose aqueous solution to make a soft material, granulated with a 40-mesh sieve, dried in an oven at 40°C for 4 hours, and then used Sieve through a 40-mesh sieve, add 0.2 g of stearic acid as an auxiliary material, mix well to obtain granules, and compress into tablets.

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PUM

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Abstract

The invention discloses a Tolterodine fumarate oral solid preparation and a preparation method thereof. The oral solid preparation is prepared from Tolterodine fumarate, starch, microcrystalline cellulose, calcium hydrogen carbonate or calcium carbonate, binder, and lubricant. The preparation method comprises the steps of: grinding raw materials, mixing, adding binder, making into damp mass, drying, grading, granulating, sub-packaging by a conventional method to obtain granules, adding lubricant, and making into capsules or tablets. The preparation method can solve content uniformity and disintegrating problems, and enable the indices of the preparation to fulfil the requirements in the Pharmacopoeia.

Description

technical field [0001] The invention relates to a medicine, in particular to an oral solid preparation of tolterodine fumarate and a preparation method thereof. Background technique [0002] The main body of tolterodine fumarate, tolterodine, is a novel muscarinic receptor antagonist developed by Pharmacia & Upjohn. It is mainly used to treat frequent urination, urgency, and urinary incontinence caused by overexcited bladder. It was first launched in Sweden in October 1997 in the form of its L-tartrate salt. Since then, it has been listed in Finland, Britain, the United States, Germany, France and other countries. [0003] Oxybutynin (oxybutynin) is the main treatment drug for such frequent urination, urgency, and urinary incontinence, but its application is limited due to its adverse reactions, especially dry mouth. In contrast, tolterodine not only has a good curative effect, but also has a lower incidence and a much milder degree of dry mouth, and cognitive impairment ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/135A61K9/00A61K47/38A61P13/00
Inventor 张英平丁敏梁隆程志鹏
Owner SICHUAN KELUN PHARMA CO LTD
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